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Development and validation of a HPLC-UV method for the determination in didanosine tablets.
J Pharm Biomed Anal. 2005 Jul 15; 38(4):751-6.JP

Abstract

A simple, rapid, sensitive and specific reversed-phase high performance liquid chromatographic method involving ultraviolet detection (HPLC-UV) was developed for analysis of didanosine in drug substance and formulated products, tablets. Chromatography was carried out on a pre-packed, Lichrospher 100 Rp-8 (5.0 microm, 250 mm x 4.0 mm) column using 0.01 M sodium acetate solution:methanol (85:15, v/v) adjusted to pH 6.5 with acetic acid as mobile phase at a flow rate of 1.5 ml/min and a 248 nm detection. Hypoxantine was confirmed as the main degradation product. The assay was linear over the concentration range of 50-150 microg/ml (R approximately 0.999). The method was validated for accuracy and precision.

Authors+Show Affiliations

de Oliveira AM
Instituto Vital Brazil, Niteroi, RJ 24310-110, Brazil. ferrcaval@ig.com.br
Löwen TC
No affiliation info available
Cabral LM
No affiliation info available
dos Santos EM
No affiliation info available
Rodrigues CR
No affiliation info available
Castro HC
No affiliation info available
dos Santos TC
No affiliation info available

MeSH

Anti-HIV AgentsCalibrationChromatography, High Pressure LiquidDidanosineDrug StabilityHydrogen-Ion ConcentrationIndicators and ReagentsOxidation-ReductionQuality ControlReference StandardsReproducibility of ResultsSpectrophotometry, UltravioletTablets

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15967304

Citation

de Oliveira, Antonia Maria Cavalcanti, et al. "Development and Validation of a HPLC-UV Method for the Determination in Didanosine Tablets." Journal of Pharmaceutical and Biomedical Analysis, vol. 38, no. 4, 2005, pp. 751-6.
de Oliveira AM, Löwen TC, Cabral LM, et al. Development and validation of a HPLC-UV method for the determination in didanosine tablets. J Pharm Biomed Anal. 2005;38(4):751-6.
de Oliveira, A. M., Löwen, T. C., Cabral, L. M., dos Santos, E. M., Rodrigues, C. R., Castro, H. C., & dos Santos, T. C. (2005). Development and validation of a HPLC-UV method for the determination in didanosine tablets. Journal of Pharmaceutical and Biomedical Analysis, 38(4), 751-6.
de Oliveira AM, et al. Development and Validation of a HPLC-UV Method for the Determination in Didanosine Tablets. J Pharm Biomed Anal. 2005 Jul 15;38(4):751-6. PubMed PMID: 15967304.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of a HPLC-UV method for the determination in didanosine tablets. AU - de Oliveira,Antonia Maria Cavalcanti, AU - Löwen,Teresa Cristina Raposo, AU - Cabral,Lúcio Mendes, AU - dos Santos,Elizabeth Moreira, AU - Rodrigues,Carlos Rangel, AU - Castro,Helena C, AU - dos Santos,Tereza Cristina, PY - 2004/08/12/received PY - 2005/02/02/revised PY - 2005/02/03/accepted PY - 2005/6/22/pubmed PY - 2005/9/20/medline PY - 2005/6/22/entrez SP - 751 EP - 6 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 38 IS - 4 N2 - A simple, rapid, sensitive and specific reversed-phase high performance liquid chromatographic method involving ultraviolet detection (HPLC-UV) was developed for analysis of didanosine in drug substance and formulated products, tablets. Chromatography was carried out on a pre-packed, Lichrospher 100 Rp-8 (5.0 microm, 250 mm x 4.0 mm) column using 0.01 M sodium acetate solution:methanol (85:15, v/v) adjusted to pH 6.5 with acetic acid as mobile phase at a flow rate of 1.5 ml/min and a 248 nm detection. Hypoxantine was confirmed as the main degradation product. The assay was linear over the concentration range of 50-150 microg/ml (R approximately 0.999). The method was validated for accuracy and precision. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/15967304/Development_and_validation_of_a_HPLC_UV_method_for_the_determination_in_didanosine_tablets_ DB - PRIME DP - Unbound Medicine ER -